Executive Director, Development Quality

Position Summary

The Executive Director, Development Quality reports into VP, R&D Quality and provides strategic and operational quality leadership across all therapeutic areas, overseeing development programs from first-in-human (FIH) through lifecycle management (LCM). As the accountable Quality partner to the Global Drug Development (GDD) and Global Development Operations (GDO), this leader provides oversight of GxP compliance, inspection readiness, and quality culture across a diverse program portfolio. This is a highly visible leadership role at the intersection of quality, science, and strategy. The ED, Development Quality is expected to be a quality champion who can engage credibly with scientists, medics clinicians, regulatory affairs professionals, and senior executives alike, driving quality not as a compliance function, but as a strategic enabler of patient-centered drug development.

This role partners with RDQ cross-pillar leaders, Global Quality, and R&D stakeholders to drive proactive quality and QMS compliance. Represents RDQ in key governance forums, overseeing the identification, escalation, and mitigation of quality and compliance risks. Serves as the single point of quality accountability across the product lifecycle, partnering with regulatory authorities, senior leadership, and cross-functional teams to embed Quality by Design and risk-based decision-making that enables innovation, speed, and sustainable growth.

Leading with an enterprise-first, transformational mindset, this role continuously evolves the Development Quality organization, simplifying processes, optimizing resources, and driving cross-functional collaboration to deliver measurable quality and compliance outcomes. The leader, where applicable, evolves the Development Quality mission, vision, and strategic roadmap in alignment with R&D Quality, Global Quality and BMS objectives, building future-ready capabilities that accelerate delivery of innovative therapies to patients.

Key Responsibilities
Strategic Quality Oversight — All Therapeutic Areas

• Define and drive the TA Quality oversight strategy, assuring quality standards are embedded from FIH through LCM across all development programs.

• Drive and oversee Trial Quality Health via Trial Quality Performance Narratives and GCP Consultation.

• Serve as the senior quality business partner to TA leadership, Drug Development, Clinical Operations, Regulatory Affairs, and Medical Affairs, providing proactive quality guidance and risk-based oversight.

• Oversee quality risk assessments and escalation management for high-impact program decisions, regulatory submissions, and post-approval changes.

• Champion a right-first-time quality culture and continuous improvement mindset across the enterprise.

• Partner with GDD/GDO leadership to align TA quality strategies with enterprise-wide quality objectives and standards.

• Lead and/or represent RDQ at key governance bodies, proactively identifying and escalating quality and compliance risks and driving resolution plans (Serious Non-Compliance/Breach Committee, R&D Quality Council, Enterprise Quality Council etc.)

• Ensure inspection readiness through proactive quality oversight, mock inspections, and CAPA management etc

• Provide leadership to Quality Investigations, Root Cause Analysis (RCA) and CAPA management for quality events

GRS-CMC Quality Business Partnership

• Provide oversight and direction to the GRS Quality Business Partner (QBP), assuring quality is integrated throughout regulatory strategy development, CMC submissions, and where applicable manufacturing changes.
• Ensure CMC quality deliverables (e.g., IND/CTA, NDA/MAA, post-approval CMC supplements) and applicable regulatory and internal standards are embedded in the trial lifecycle.
• Provide oversight to complex CMC/GRS issues, including out-of-specification investigations, manufacturing deviations, and regulatory agency queries.
• Support GRS-CMC QBP on oversight of Data Stewards and RIM Services to establish and maintain data quality standards within RIM systems and related metrics.
• Support GRS-CMC QBP to oversee Global Regulatory Policy team where appropriate.
• Partner with Product Development Quality (PDQ) CMC team members where applicable in driving quality outcomes.

Medical Affairs & Lifecycle Management Quality Business Partnership

• Provide oversight and strategic direction to the Medical Affairs & LCM Quality Business Partner, embedding quality oversight in all Non-Intervantional, Health Economics, Patient Support Programs (PSP) and other post-approval programs for label expansions, line extensions, and medical affairs operations.

• Assure QMS compliance (GCP, GVP, GDocP, Good Publication Policy etc.) for Medical Affairs-sponsored studies, PSP, and Real-World Evidence (RWE) activities..

• Provide oversight to Medical Affairs and LCM QBP to establish and maintain quality frameworks for medical information, publication planning, and field medical activities where GxP obligations apply.

• Lead quality review and oversight of promotional and medical affairs materials where quality oversight is required.

Audit Readiness, Inspection Readiness & Regulatory Agency Interactions

• Partner with RDQ pillars and relevant stakeholders to assure state of audit readiness and provide input into audit strategy and execution

• Partner with RDQ pillars and stakeholders to assure state of continuous inspection readiness across all TA programs and the Medical Affairs/LCM portfolio.

• Partner in preparation and management of regulatory authority inspections (FDA, EMA, PMDA, and other global health authorities) related to development and medical affairs operations.

• Serve as primary quality contact during regulatory inspections; manage responses to inspection observations and audit findings where applicable.

• Partner cross RDQ pillar leads to track and trend inspection outcomes, Quality Events, audit findings to drive systemic improvements and CAPA effectiveness.

Quality Systems, Compliance & Governance

• Oversee implementation and maintenance of quality systems relevant to development, PSP and medical affairs (deviation management, CAPA, change control, vendor qualification).

• Establish and monitor quality metrics and KPIs for the portfolio; present to senior leadership and governance bodies on quality performance and risk where appropariate.

• Ensure timely escalation of critical quality issues to senior Quality and GDD/GDO leadership.

• Represent RDQ on relevant quality councils and other committees as the TA Quality representative.

People Leadership & Organizational Development

• Provides leadership, coaching, and development for direct reports, building organizational capability and cultivating a high-performing team aligned with strategic objectives.

• Build team capability through coaching, performance management, and career development planning.

• Model and reinforce a culture of quality, accountability, and psychological safety.

• Attract and retain top quality talent; resource the TA Quality function appropriately to meet portfolio demands.

• Foster a collaborative, cross-functional partnership mindset within the quality team.

• Represent BMS at external and cross-industry bodies.

• Budget Management for team and RDQ when applicable

• Bachelor's or higher degree in a scientific discipline (Life Sciences, Pharmacy, Chemistry, or related field); advanced degree (MS, PhD, PharmD) strongly preferred.

• Minimum 15–20 years of progressive pharmaceutical/biotech industry experience, with at least 10 years in Quality roles or equivalent within Development, Regulatory, or Medical Affairs contexts.

• Demonstrated experience providing quality oversight across multiple therapeutic areas and development phases (FIH through NDA/MAA and post-approval).

• Deep knowledge of GCP, GVP and other GxPs including understanding of global regulatory frameworks (ICH guidelines, FDA, EMA, MHRA, CFDA, PMDA regulations).

• Proven track record leading or managing regulatory authority inspections (FDA, EMA, or equivalent) and responding to inspection observations.

• Experience in regulatory activities, including IND/NDA/MAA and post-approval CMC change management.

• Demonstrated people leadership experience, including building and developing high-performing quality teams.

• Exceptional stakeholder management skills and ability to influence without authority at senior levels.

• Strong analytical, communication, and executive presentation skills.

Preferred

• Experience in a global biopharmaceutical organization with cross-functional matrix leadership.

• Familiarity with GxP quality systems (e.g., Veeva Vault QMS, CTMS, eTMF) and quality risk management methodologies (ICH Q9).

• Prior experience as a Quality Business Partner embedded within a TA or development organization.

• Exposure to novel modalities (gene therapy, cell therapy, biologics, or RNA-based therapies) is a plus.

Leadership & Strategic Thinking-Technical Quality Expertise

• Drives quality vision and strategy

• Leads through ambiguity and complexity

• Develops and retains talent

• Influences senior stakeholders

• GxP regulatory knowledge (GCP/GVP/GLP)

• Inspection management expertise

• Risk-based quality management

• CMC and LCM quality oversight

Cross-Functional Partnership-Execution & Results Orientation

• Trusted advisor to TA and Medical Affairs leadership

• Effective communicator across organizational levels

• Collaborative yet decisive

• Prioritizes and manages multiple program demands

• Delivers quality outcomes on time

• Continuous improvement mindset

#LI-Hybrid